NCT05285839招募中4 期
Single Center, Pilot Study to Evaluate the Effectiveness and Safety of Dupilumab in Combination With Narrowband UVB (nUVB) Phototherapy in the Treatment of Moderate-to-Severe Atopic Dermatitis
Psoriasis Treatment Center of Central New Jersey1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年4月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Investigators Global Assessment Score of score of 0 or 1
研究概览
简要总结
24 weeks open-label study with dupilumab and narrowband UVB phototherapy three times weekly for 12 weeks followed by 12 weeks of dupilumab monotherapy.
详细描述
24 weeks open-label study with dupilumab and narrowband UVB phototherapy three times weekly for 12 weeks followed by 12 weeks of dupilumab monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult ≥ 18 years of age;
- •Diagnosis of moderate to severe atopic dermatitis as defined at baseline by:
- •EASI score of 16 or greater,
- •IGA score of 3 or greater
- •BSA of 10% or greater,
排除标准
- •Subjects with previous exposure to dupilumab.
- •Known or suspected hypersensitivity to dupilumab or any of its excipients.
- •History of photosensitivity.
研究组 & 干预措施
Dupixent and Narrowband UVB
Experimental
Dupixent and Narrowband UVB
干预措施: Dupixent (Drug)
结局指标
主要结局
Investigators Global Assessment Score of score of 0 or 1
时间窗: 12 weeks
Proportion of subjects achieving an IGA score of 0 or 1 with at least a 2 grade improvement at week 12
次要结局
未报告次要终点
研究者
研究点 (1)
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